European Medicines Agency approves decitabine
Decitabine is intended for the treatment of patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia
- Date : 07 Aug 2012
- Topic : Anticancer agents & Biologic therapy
On 19 July 2012, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product decitabine (Dacogen), 50 mg, powder for concentrate for solution for infusion, intended for the treatment of acute myeloid leukaemia.
Decitabine was designated as an orphan medicinal product on 8 June 2006. The applicant for this medicinal product is Janssen-Cilag International NV. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
How does decitabine work?
The active substance of Dacogen is decitabine, a pyrimidine analogue (L01BC08). It is a cytosine nucleoside analogue which inhibits DNA methyltransferase. The benefits with decitabine are its ability to show an increase in overall survival. The most common side effects are pyrexia, pneumonia, thrombocytopenia, anaemia, febrile neutropenia, neutropenia, nausea and diarrhoea.
A pharmacovigilance plan for decitabine will be implemented as part of the marketing authorisation.
The approved indication is: “Dacogen is indicated for the treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy”. It is proposed that decitabine be prescribed by physicians experienced in the use of chemotherapeutic agents.
Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for decitabine and therefore recommends the granting of the marketing authorisation.
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